Back to results

A Study to Investigate the Pharmacodynamic Effects of CT327 on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers

Primary Purpose

Neuropathic Pain

Status

Completed

Phase

Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

CT327 (or placebo) followed by placebo (or CT327)

About this trial

This is an interventional basic science trial for Neuropathic Pain

Eligibility Criteria

18 Years - 64 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Subjects must be able to understand the contents of the study, comply with the study and willing to sign informed consent
Subjects must be free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests
All male subjects must take adequate contraceptive precautions during the course of the study and for 30 days after their participation in the study has ended

Exclusion Criteria:

Participation in other clinical studies within 3 months before screening
Scheduled for surgery, medical treatment or any hospital admission that would fall within the study
Use of strong painkillers
Use of any analgesic within 24 hours before start of study
Use of a regular course of prescribed medication and/or herbal medicine
The presence of lesions, significant scars, cuts, wounds, dermal abnormalities, tattoos or naevi in the test areas
A past history of contact dermatitis, psoriasis or keloid
Any clinically significant ECG abnormality at screening
A history of drug or other allergy that contraindicates his participation.
Regular or average consumption of more than 21 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 125 mL of wine or 20 mL of spirits).
Smokes more than five cigarettes (on average) per day, or had been a smoker of more than 5 cigarettes (on average) per day within the 3 months prior to screening.
A known history of drug or alcohol abuse.
As a result of the medical screening process, the PI or medical delegate considers the subject unfit for the study.
Use of any prescription medication within 2 weeks or 5 half-lives (whichever is longer) of dosing.
Use of non-prescription medication (e.g. aspirin, vitamins and herbal and dietary supplements) within 7 days prior to dosing, or 14 days if the medication contained grapefruit/ grapefruit juice or St John's Wort.

Sites / Locations

Department of Gastroenterology Aalborg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

CT327 treatment period 1

CT327 treatment period 2

Arm Description

Subjects in Group 1 will receive CT327 during treatment/testing period 1 and placebo during treatment/testing period 2

Subjects in Group 2 will receive placebo during treatment/testing period 1 and CT327 during treatment/testing period 2

Outcomes

Primary Outcome Measures

An alteration in the peripheral sensitisation after treatment with CT327

Secondary Outcome Measures

The change in pain determined with the visual analogue scale (VAS) and the change in areas assessed with von Frey filaments and standardized brush.

Full Information

NCT ID

NCT01243307

First Posted

November 17, 2010

Last Updated

June 6, 2011

Sponsor

Creabilis SA

Collaborators

Aalborg University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01243307

Brief Title

A Study to Investigate the Pharmacodynamic Effects of CT327 on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers

Official Title

A Phase I, Single-centre, Multiple-dose, Placebo-controlled Crossover Study to Investigate the Pharmacodynamic Effects of CT327 (0.1% Topical Cream) on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Creabilis SA

Collaborators

Aalborg University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to compare the effect of CT327 to placebo against experimental induced superficial, deep and hyperalgesic pain. The secondary objectives are to elucidate the mechanisms of CT327 using experimental pain models.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CT327 treatment period 1

Arm Type

Experimental

Arm Description

Subjects in Group 1 will receive CT327 during treatment/testing period 1 and placebo during treatment/testing period 2

Arm Title

CT327 treatment period 2

Arm Type

Experimental

Arm Description

Subjects in Group 2 will receive placebo during treatment/testing period 1 and CT327 during treatment/testing period 2

Intervention Type

Drug

Intervention Name(s)

CT327 (or placebo) followed by placebo (or CT327)

Intervention Description

During treatment/testing period 1, subjects will apply 0.25 g CT327 (or placebo) to 4 test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications. During treatment/testing period 2, subjects will apply 0.25 g placebo (or CT327) to 4 different test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications.

Primary Outcome Measure Information:

Title

An alteration in the peripheral sensitisation after treatment with CT327

Time Frame

2 treatment/testing periods each lasting 4 days and separated by at least 10 days

Secondary Outcome Measure Information:

Title

The change in pain determined with the visual analogue scale (VAS) and the change in areas assessed with von Frey filaments and standardized brush.

Time Frame

2 treatment/testing periods each lasting 4 days and separated by at least 10 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must be able to understand the contents of the study, comply with the study and willing to sign informed consent Subjects must be free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests All male subjects must take adequate contraceptive precautions during the course of the study and for 30 days after their participation in the study has ended Exclusion Criteria: Participation in other clinical studies within 3 months before screening Scheduled for surgery, medical treatment or any hospital admission that would fall within the study Use of strong painkillers Use of any analgesic within 24 hours before start of study Use of a regular course of prescribed medication and/or herbal medicine The presence of lesions, significant scars, cuts, wounds, dermal abnormalities, tattoos or naevi in the test areas A past history of contact dermatitis, psoriasis or keloid Any clinically significant ECG abnormality at screening A history of drug or other allergy that contraindicates his participation. Regular or average consumption of more than 21 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 125 mL of wine or 20 mL of spirits). Smokes more than five cigarettes (on average) per day, or had been a smoker of more than 5 cigarettes (on average) per day within the 3 months prior to screening. A known history of drug or alcohol abuse. As a result of the medical screening process, the PI or medical delegate considers the subject unfit for the study. Use of any prescription medication within 2 weeks or 5 half-lives (whichever is longer) of dosing. Use of non-prescription medication (e.g. aspirin, vitamins and herbal and dietary supplements) within 7 days prior to dosing, or 14 days if the medication contained grapefruit/ grapefruit juice or St John's Wort.

Facility Information:

Facility Name

Department of Gastroenterology Aalborg Hospital

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

A Study to Investigate the Pharmacodynamic Effects of CT327 on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers

We'll reach out to this number within 24 hrs